Surgical implantation of tissue is utilized to replace and/or repair human tissues. For example, hereditary defects, disease, and/or trauma may damage tissues such that replacement and/or repair is desirable. These implantable tissues may be provided by individual human donors. However, because of the scarcity of appropriate human donors, non-human tissues have been increasingly employed instead. Such biological tissues have been used to replace heart valves, ligaments, tendons and skin, among other tissues.
Care must be taken in preparing, manufacturing, storing, and shipping these replacement materials. While many have focused on the design and construction of the replacement materials themselves, fewer have focused on the structures that would aide in constructing, evaluating, and storing biological material such as heart valves and vascular grafts.
For example, some devices or methods have tried to accomplish the culturing under subphysiologic conditions. There is a need for a system and apparatus for evaluating biological material under normal and supra-physiological conditions. Some of this need is represented by a need to modify the current pulse duplicator and accelerated life testers.
Furthermore, testing and monitoring methods and devices are typically not conducted in sterile and aseptic conditions. Mounting the fixture in a sealable chamber for use in storage and shipping has not been accomplished. There is a need to provide a system and apparatus that provides a sterile environment throughout the construction, testing, and storage stages. This need extends to providing a test and evaluation container that also may be used as a storage and shipping container.
Furthermore, the design of some of the equipment for working with biological material, such as the mandrels for working with heart valves and vascular grafts, are sometimes awkward to use and do not adequately address the problems of the entire manufacturing process. For example, a single valve mounting and release system has not been accomplished. There is a need to provide a new mounting system for biological materials.